FDA Takes Aim at Abuse-Deterrent Opioids

New FDA Commissioner Scott Gottlieb, MD, says the agency wants to know
whether abuse-deterrent prescription opioids "are having their intended
impact on limiting abuse and helping to curb the epidemic."

To help get a meaningful answer, Gottlieb has called a public meeting for
July 10 and 11, 2017, to "engage external thought leaders in a discussion
about how we can better leverage existing data sources and methods to
evaluate the impact of these products in the real world." The meeting
will seek to find or create "new data sources and study designs to
ensure the best possible answers" about abuse-deterrent formulations
which will influence regulatory decision-making.

Abuse-deterrent prescription opioids are designed to "deter"
abuse by various methods, such as snorting or injecting. Some formulations
make crushing a pill to dissolve it in a liquid for injection or into
a powder for snorting more difficult. Others combine naloxone with the
main active ingredient to block the "high" of the opioid. "This
has been an important area of innovation that the FDA continues to support,"
Gottlieb said. "However, we recognize that there is a gap in our
understanding of whether these products result in a real-world, meaningful
decrease in the frequency and patterns of opioid misuse and abuse."

For anyone interested in attending the public meeting or learning more
about the issues involved, the agency has made available for download an
issues paper outlining existing regulatory and public health challenges. As we
reported two weeks ago, the new Commissioner told his first staff meeting that
"our greatest immediate challenge is the problem of opioid abuse."
This was followed by the news a week later that the FDA has asked for
an abuse-deterrent prescription painkiller, Opana ER, to be taken off
the market because it's been so widely abused.

"Opioid formulations with properties designed to deter abuse are not
abuse-proof or addiction-proof," Gottlieb said in a
lengthy statement about expanding the FDA's role in combating the opioid epidemic. "These
drugs can still be abused, particularly orally, and their use can still
lead to new addiction." However, the Commissioner said, these new
formulations "may hold promise" as part of a broad effort to
reduce abuse. "We recognize there is a gap in our understanding of
whether these products result in a real world, meaningful decrease in
the frequency and patterns of opioid misuse and abuse," he said.
"One thing is clear: We need better scientific information to understand
how to optimize our assessment of abuse deterrent formulations."

In his statement, Gottlieb said that "everyone at the FDA is committed
to focusing on all aspects of the epidemic." As part of this program,
a steering committee is being formed to examine "additional regulatory
and policy actions to combat this crisis" that can reduce the number
of new cases of addiction. The FDA has just published a paper,
FDA Facts: Abuse-Deterrent Opioid Medications, that details the agency's strong support for abuse deterrence formulations.
It says that opioids with abuse-deterrent properties are, as Gottlieb
says, "not abuse-proof." But the agency points out that they
are "a step toward products that will help reduce abuse."

The agency "fully supports efforts to better understand the impact
of these products in the real-world setting and develop innovative formulations
that have the potential to make abuse of these products more difficult
or less rewarding," the paper says. "The FDA is working with
many drug makers to support advancements in this area and help drug makers
navigate the regulatory path to market as quickly as possible. In working
with industry, the FDA is taking a flexible, adaptive approach to the
evaluation and labeling of potentially AD products." Here's a
list of the currently approved brand-name abuse-deterrent prescription
opioids on the market.

No generic versions have yet been approved for abuse-deterrent labeling:
The FDA has approved the following opioids with labeling describing AD
properties consistent with the FDA's
Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling:

OxyContin -
oxycodone, Purdue Pharma

Targiniq ER -
oxycodone and naloxone, Purdue Pharma

Embeda -
morphine and naltrexone, Pfizer Inc.

Hysingla ER -
hydrocodone, Purdue Pharma

MorphaBond -
morphine, Daiichi Sankyo, Inc.

Xtampza ER -
oxycodone, Collegium Pharmaceutical Inc

Troxyca ER -oxycodone and naltrexone, Pfizer Inc.

Arymo ER -
morphine, Egalet Corp.

Vantrela ER -
hydrocodone, Teva Pharm.

RoxyBond -
oxycodone, Inspirion

We can certainly see the popularity of oxycodone - half of the 10 approved
formulations are built around that drug. Three are morphine and two are
hydrocodone. Three are designed with the antagonists naloxone or naltrexone,
the rest with some sort of crush and dissolve resistance. It does look
like the FDA is working hard to be responsive to the opioid epidemic.
Meanwhile we are working hard to help those that want to end their dependency
on opioids.

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